Generalized Anxiety Disorder
Conditions
Brief summary
We are investigating the feasibility and efficacy of transcranial magnetic stimulation (TMS) for patients with GAD who were placebo nonresponders in DIEF003523.1.
Detailed description
We expected to enroll five patients with GAD who failed to respond to a sham (placebo) TMS intervention. In this pilot study we enrolled three participants into a protocol including 10 rTMS sessions (twice a week for five weeks) and one into a protocol including 15 rTMS sessions (three times a week for five weeks). Assessments occurred at pretreatment and at posttreatment.
Interventions
DEVICErTMS Treatment
Either 10 or 15 rTMS sessions (2 or 3 times/week for 5 weeks, respectively)
Sponsors
Neuronetics
Hartford Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participated in the study DIEF003523.1, received sham placebo TMS and achieved \< 50% improvement in HARS at 3 month follow-up. * Fluency in English * Capacity to understand the nature of the study and willingness to sign informed consent form
Exclusion criteria
* History of epilepsy or head trauma (LOC \> 5 minutes) within the past 6 months * Lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis, or brain surgery * A review of patient medications by the study physician indicates an increased risk of seizure * An active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency * Substance use disorder or PTSD within the past 6 months * Lifetime bipolar disorder, obsessive-compulsive disorder (OCD), psychotic disorder, mental retardation, or pervasive developmental disorder * Any psychotic features, including dementia or delirium * Concurrent psychotherapy and unwillingness to discontinue * Medication change within the past 4 weeks * Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within the past 6 months * Serious, unstable, or terminal medical condition or clinically judged too psychiatrically unstable to participate in the study * Any contraindication for participation in MRI scan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment. | Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session | The Hamilton Anxiety Rating Scale (HARS) is one of the most commonly used and extensively validated outcome measures for anxiety symptoms. The SIGH-A allows for a standardized administration of the HARS. The total score was used in this study. The total score ranges from 0 to 56 with higher scores indicative of more severe anxiety symptoms. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| rTMS Treatment rTMS Treatment: will entail twice weekly rTMS sessions for 5 weeks. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | unable to attend study visits | 1 |
Baseline characteristics
| Characteristic | rTMS Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 42.75 years STANDARD_DEVIATION 15.1 |
| Region of Enrollment United States | 4 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment.
The Hamilton Anxiety Rating Scale (HARS) is one of the most commonly used and extensively validated outcome measures for anxiety symptoms. The SIGH-A allows for a standardized administration of the HARS. The total score was used in this study. The total score ranges from 0 to 56 with higher scores indicative of more severe anxiety symptoms.
Time frame: Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session
Population: rTMS treatment completers
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre rTMS Treatment | Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment. | 20.00 units on a scale | Standard Deviation 4.24 |
| Post rTMS Treatment | Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment. | 10.50 units on a scale | Standard Deviation 0.71 |